Form 483 · FEI 3017604745
Form 483 issued September 7, 2022 · Bandar Baru Enstek, Malaysia
- Inspection
- Sep 1 – Sep 7, 2022
- Investigator
- Santos E. Camara
- Observations
- 3
- Pages
- 2
- FEI number
- 3017604745
In short: On September 7, 2022, FDA issued a Form 483 with 3 observations to an FDA-inspected site in Bandar Baru Enstek, Negeri Sembilan (FEI 3017604745) after an inspection that ran Sep 1 – Sep 7, 2022. The investigator was Santos E. Camara. Most observations concern production and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment…
- 02
All major equipment used during the production of a batch of drug product is not properly…
- 03
Deviations from written production and process control procedures are…
This inspection in context
Santos E. Camara
33 documents · 2015–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 3 observations on this Form 483, mostly about production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Santos E. Camara is named on this Form 483, for the inspection of Sep 1 – Sep 7, 2022. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Sep 1 – Sep 7, 2022, and the Form 483 is dated September 7, 2022.
How do I get the full Form 483 for an FDA-inspected site?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.